Regeneron Pharmaceuticals, Inc.announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD^® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. The data were presented today at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual meeting and will support the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025.

“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” said Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago. “Based on these new data, aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies.”

As presented at Angiogenesis, the QUASAR trial met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA^® (aflibercept) Injection 2 mg dosed every 4 weeks. The EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Furthermore, in patients treated with EYLEA HD through 36 weeks, 88% of patients were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.

The safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment-emergent adverse events (TEAEs) occurring in ≥5% of all EYLEA HD patients included increased ocular pressure (5%); there was one case each of endophthalmitis and retinal vasculitis. The rate of intraocular inflammation was 0.5% for EYLEA HD and 1.3% for EYLEA.

EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD.

The safety and efficacy of EYLEA HD for the treatment of RVO has not been evaluated by any regulatory authority.